Is Cabenuva (cabotegravir and rilpivirine) appropriate for a patient with HIV who has achieved viral suppression and a CD4 count of 182, and should ibalizumab (Trogarzo) be discontinued?

Recommendation for Cabenuva and Ibalizumab in Virologically Suppressed HIV Patient

Approve Cabenuva (cabotegravir/rilpivirine) for this virologically suppressed patient with CD4 count of 182, and immediately discontinue ibalizumab (Trogarzo) as it is only indicated for multidrug-resistant HIV with ongoing virologic failure—continuing this salvage therapy in a patient with complete viral suppression (<20 copies/mL) is clinically inappropriate and wasteful. 1, 2

Rationale for Cabenuva Approval

Eligibility Criteria Met

• This patient meets all criteria for long-acting injectable therapy: maintained HIV-1 RNA <50 copies/mL (currently <20 copies/mL) for at least 6 months on current regimen without history of virological failure 2, 3
• No documented resistance to cabotegravir or rilpivirine based on the clinical scenario provided, which is essential for Cabenuva use 2, 4
• Virologic suppression is the key eligibility criterion, not CD4 count—the CD4 of 182 does not preclude use of Cabenuva 5, 6

Evidence Supporting Use in This Population

• Long-acting cabotegravir plus rilpivirine maintained viral suppression in 95% of patients at 96 weeks in the FLAIR and ATLAS trials, demonstrating durable efficacy 5, 7
• Recent real-world data show 80% viral suppression at 48 weeks even in patients starting with viremia, suggesting excellent outcomes in adherent patients who are already suppressed 6
• The FDA-approved indication specifically includes virologically suppressed adults switching from their current antiretroviral regimen 3

Implementation Algorithm

• Recommend oral lead-in phase of 4-5 weeks with oral cabotegravir 30mg plus rilpivirine 25mg daily to assess tolerability before committing to long-acting injections 2, 3
• Check HIV RNA at 4-6 weeks after starting oral lead-in to confirm maintained viral suppression 2
• If oral lead-in successful, proceed to long-acting injections: cabotegravir 400mg plus rilpivirine 600mg intramuscularly every 4 weeks initially, with option to extend to every 8 weeks after establishing tolerance 2, 3
• Monitor HIV RNA every 3 months for the first year after switching to long-acting therapy 2

Critical Caveats

• Risk of virologic failure with resistance is 1-2% even with perfect adherence, and when failure occurs, 75% develop rilpivirine resistance and 60% develop integrase inhibitor resistance 2
• Patient must be able to attend scheduled injections reliably—poor injection adherence is a risk factor for virologic failure 2
• Injection site reactions occur in 88% of patients but are typically grade 1-2, lasting median 3 days, and rarely lead to discontinuation 5

Rationale for Ibalizumab Discontinuation

Indication Mismatch

• Ibalizumab is indicated exclusively for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen 1
• The FDA approval was based on patients with virologic failure from multidrug-resistant HIV, where almost 50% achieved undetectable HIV RNA at 24 weeks when ibalizumab was combined with at least one other active drug 1
• This patient has the opposite clinical scenario: complete viral suppression with undetectable viral load (<20 copies/mL), making ibalizumab use inappropriate 1

Clinical and Economic Considerations

• Ibalizumab is a salvage therapy reserved for patients with limited treatment options due to extensive resistance 1
• Continuing expensive salvage medication in a virologically suppressed patient with no evidence of resistance is not evidence-based and represents poor stewardship of resources 1
• The patient's current viral suppression indicates their regimen is working—there is no clinical rationale for maintaining a drug designed for treatment failure 1

Quality of Life and Morbidity Considerations

Benefits of Switching to Cabenuva

• Reduced pill burden from daily oral tablets to 6 injections per year (if using every 8-week dosing) improves quality of life 2
• Potential metabolic benefits including reduction in NRTI-related bone, kidney, and cardiovascular complications by eliminating daily oral NRTIs 2
• Maintains durable virological suppression with 95% suppression rates in clinical trials, prioritizing the key outcome of preventing HIV-related morbidity and mortality 2

Monitoring for Low CD4 Count

• CD4 count of 182 requires continued monitoring every 6 months until above 250/μL for at least 1 year with concomitant viral suppression 1
• The low CD4 count does not contraindicate Cabenuva but does require attention to opportunistic infection prophylaxis per standard guidelines 1

Certification Recommendations

Recommend Certification:

• J0741 (cabotegravir injection)
• 96372 (therapeutic injection, subcutaneous or intramuscular)
• 96365 (intravenous infusion, for therapy, prophylaxis, or diagnosis, initial)
• J0742 (rilpivirine injection)

Recommend Non-Certification:

• J1746 (ibalizumab injection) - inappropriate for virologically suppressed patient without multidrug resistance 1